Industry News - Tag: EMA

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Regulatory in brief | CHMP, vitamin D, corticosteroids

24 September 2021

The European Union’s Committee for Medicinal Products for Human Use (CHMP) has re-elected Harald Enzmann as chair, France has warned about vitamin D overdoses in infants, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has added a warning about steroid withdrawal reactions to...

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Regulatory in brief | Allopurinol, PRAC, MHRA

8 September 2021

New Zealand's Medicines Classification Committee (MCC) is set to reconsider an application to change the status of allopurinol for preventing gout, Europe’s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the mandate of its vice chair for a further three years, and the UK’s Medicines...

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Regulatory in brief | EMA/HMA, CBD, loperamide

8 December 2020

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published a joint strategy to 2025, the European Court of Justice (ECJ) has released a judgement on cannabidiol (CBD), and Denmark has made changes to the sale of loperamide medicines.

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Regulatory in brief | switches, paracetamol, ulipristal

11 September 2020

A parliamentary group in the UK wants the progestogen-only pill to be made available without a prescription, research claims a link between paracetamol and risk taking, and Europe recommends withdrawing the marketing authorisation for a prescription version of ulipristal acetate.

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